| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01024-1 |
| Product Name/Description |
Medtronic CareLink 2090 Programmer (Implantable pacemaker programmer)
Affected serial numbers: PKK010877R, PKK054660R
ARTG Number: 116038 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified that a small subset of 2090 Programmers have an incorrect software configuration for the country in which that are physically located. When a programmer is manufactured, it is configured for the region in which it will be located. In this way, Medtronic is able to differentiate the timing of software updates across different regions of the globe. Through the investigation of this issue, a small subset of programmers have been determined to be physically located in a country outside of the region for which they are configured. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is requesting users to return affected devices for re-configuration. Medtronic representative will contact customers to coordinate the servicing and return of the programmer. |
| Contact Information |
1800 668 670 - Medtronic Australasia |